Clinical trial · Interventional
SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist
Prospective Study of Stereotactic Body Radiation Therapy as a Bridging Therapy for Hepatocellular Carcinoma Patients on Waiting List for Liver Transplantation
NCT03950102CI-TRIAL-00038806unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- SBRT will be used as the primary bridging therapy for HCC patients on waitlist
- interventionNames
- Radiation: SBRT
Primary outcomes (2)
- measure
- Risk of classical radiation induced liver disease (RILD) after SBRT
- timeFrame
- From time of SBRT to 3 months afterwards
- description
- Defined as elevated liver transaminases \>5 times of upper normal limit or worsening of Child's score by \>2 within 3 months after SBRT
- measure
- Rate of transplant complication
- timeFrame
- From time of transplant to 1 months afterwards
- description
- Perioperative complication will be assessed according to Clavien-Dindo classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Radiological diagnosis of HCC confirmed according to AASLD criteria 2. All patients who are accepted on deceased donor waiting list 3. HCC within UCSF criteria (defined as solitary tumor \<=6.5cm OR up to 3 tumors \<=4.5cm, total sum \<=8cm) Exclusion Criteria: 1. age \<18 year old; 2. Child's C cirrhosis; 3. Eastern Cooperative Oncology Group (ECOG) score \>2; 4. presence of extrahepatic metastasis; 5. radiological tumor invasion to portal, hepatic vein or its branches; 6. absolute contraindications to RT (e.g. previous RT to liver); 7. positive pregnancy test; 8. unwilling or unable to adhere to study requirements and procedure; 9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.
References
Publications (1)
- DERIVEDWong TC, Lee VH, Law AL, Pang HH, Lam KO, Lau V, Cui TY, Fong AS, Lee SW, Wong EC, Dai JW, Chan AC, Cheung TT, Fung JY, Yeung RM, Luk MY, Leung TW, Lo CM. Prospective Study of Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma on Waitlist for Liver Transplant. Hepatology. 2021 Nov;74(5):2580-2594. doi: 10.1002/hep.31992. Epub 2021 Sep 30. PMID 34091914